Habib Samady

Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial

BACKGROUNDnPercutaneous coronary intervention (PCI) is most commonly guided by angiography alone. Intravascular ultrasound (IVUS) guidance has been shown to reduce major adverse cardiovascular events (MACE) after PCI, principally by resulting in a larger postprocedure lumen than with angiographic guidance. Optical coherence tomography (OCT) provides higher resolution imaging than does IVUS, although findings from some studies suggest that it might lead to smaller luminal diameters after stent implantation. We sought to establish whether or not a novel OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with IVUS guidance and better than that achieved with angiography guidance alone.nnnMETHODSnIn this randomised controlled trial, we recruited patients aged 18 years or older undergoing PCI from 29 hospitals in eight countries. Eligible patients had one or more target lesions located in a native coronary artery with a visually estimated reference vessel diameter of 2·25-3·50 mm and a length of less than 40 mm. We excluded patients with left main or ostial right coronary artery stenoses, bypass graft stenoses, chronic total occlusions, planned two-stent bifurcations, and in-stent restenosis. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratified by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging (operators in the IVUS and angiography groups were masked to the OCT images). The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of enrolment, in all randomly allocated participants who had primary outcome data. The primary safety endpoint was procedural MACE. We tested non-inferiority of OCT guidance to IVUS guidance (with a non-inferiority margin of 1·0 mm2), superiority of OCT guidance to angiography guidance, and superiority of OCT guidance to IVUS guidance, in a hierarchical manner. This trial is registered with ClinicalTrials.gov, number NCT02471586.nnnFINDINGSnBetween May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158 [35%] to OCT, 146 [32%] to IVUS, and 146 [32%] to angiography), with 415 final OCT acquisitions analysed for the primary endpoint (140 [34%] in the OCT group, 135 [33%] in the IVUS group, and 140 [34%] in the angiography group). The final median minimum stent area was 5·79 mm2 (IQR 4·54-7·34) with OCT guidance, 5·89 mm2 (4·67-7·80) with IVUS guidance, and 5·49 mm2 (4·39-6·59) with angiography guidance. OCT guidance was non-inferior to IVUS guidance (one-sided 97·5% lower CI -0·70 mm2; p=0·001), but not superior (p=0·42). OCT guidance was also not superior to angiography guidance (p=0·12). We noted procedural MACE in four (3%) of 158 patients in the OCT group, one (1%) of 146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT vs IVUS p=0·37; OCT vs angiography p=0·37).nnnINTERPRETATIONnOCT-guided PCI using a specific reference segment external elastic lamina-based stent optimisation strategy was safe and resulted in similar minimum stent area to that of IVUS-guided PCI. These data warrant a large-scale randomised trial to establish whether or not OCT guidance results in superior clinical outcomes to angiography guidance.nnnFUNDINGnSt Jude Medical.

Prevalence and characteristics of TCFA and degree of coronary artery stenosis: an OCT, IVUS, and angiographic study.

BACKGROUNDnThe relationship between features of vulnerable plaque and angiographic coronary stenosis is unknown.nnnOBJECTIVESnThe purpose of this study was to systematically investigate the absolute number, relative prevalence, and characteristics of thin-cap fibroatheroma (TCFA) at different degrees of stenosis using optical coherence tomography (OCT), intravascular ultrasound, and coronary angiography.nnnMETHODSnWe identified 643 plaques from 255 subjects who underwent OCT imaging in all 3 coronary arteries. They were divided into 3 groups on the basis of angiographic diameter stenosis: Group A (30% to 49%, nxa0= 325), Group B (50% to 69%, nxa0= 227), and Group C (>70%, nxa0= 91).nnnRESULTSnOCT showed that the absolute number of TCFA was greatest in Group A (nxa0= 58), followed by Groups B (nxa0= 40) and C (nxa0= 33). However, the relative prevalence of TCFA was higher in Group C (36%) than in Groups A (18%) or B (18%) (pxa0= 0.003 and pxa0= 0.002, respectively). Fibrous cap of TCFA was thinner in Group C than in Groups A (pxa0< 0.001) or B (pxa0= 0.001). intravascular ultrasound showed that the plaque burden of TCFA was largest in Group C (80.1 ± 7.4%), compared with Groups B (67.5 ± 9.4%) and A (58.1 ± 8.4%). TCFA in Group C had a higher remodeling index than those in Group A (pxa0= 0.002).nnnCONCLUSIONSnThe absolute number of TCFA is 3 times greater in nonsevere stenosis than in severe stenosis. It is, however, twice as likely for a lesion to be TCFA in cases of severe stenosis than in nonsevere stenosis. Moreover, TCFA inxa0severely-stenotic areas had more features of plaque vulnerability.

Evaluation of a fully bioresorbable vascular scaffold in patients with coronary artery disease: Design of and rationale for the ABSORB III randomized trial

BACKGROUNDnRandomized trials have demonstrated progressive improvements in clinical and angiographic measures of restenosis with technologic iterations from balloon angioplasty to bare-metal stents and subsequently to drug-eluting stents (DES). However, the permanent presence of a metal stent prevents coronary vasomotion, autoregulation, and adaptive coronary remodeling. The limitations imposed by a permanent metal implant may be overcome with a bioresorbable scaffold. ABSORB III is a large-scale, multicenter, randomized trial designed to support US premarket approval of the ABSORB BVS platform and is the first study with sufficient size to allow valid examination of the relative clinical outcomes between metallic DES and bioresorbable scaffold.nnnDESIGNnABSORB III (ClincalTrials.gov NCT01751906) will register approximately 2,262 patients and includes a lead-in phase (n = 50), the primary randomized analysis group (n = 2,000), an imaging cohort (n = 200), and a pharmacokinetic substudy (n = 12). In the primary analysis group, approximately 2,000 patients with up to 2 de novo native coronary artery lesions in separate epicardial vessels will be prospectively assigned in a 2:1 ratio to ABSORB BVS versus XIENCE everolimus-eluting stents (EES). The primary end point is target lesion failure (the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year, powered for noninferiority of ABSORB BVS compared to XIENCE EES. Clinical follow-up will continue for 5 years. Enrollment has been completed, and the principal results will be available in the fall of 2015.nnnCONCLUSIONSnThe large-scale ABSORB III randomized trial will evaluate the safety and effectiveness of ABSORB BVS compared to XIENCE EES in the treatment of patients with coronary artery disease.

The use of hemodynamic support in massive pulmonary embolism

Massive pulmonary embolism is life threatening and can present as cardiogenic shock and cardiac arrest. We report a case of a 47‐year‐old male who arrested during his postoperative hospitalization and was found to have a massive pulmonary embolism with bilateral involvement of the pulmonary arteries. Given his profound shock and right ventricular failure, an Impella RP was used to stabilize his acute right ventricular failure while percutaneous embolectomy and thrombolysis was used to treat the pulmonary embolism. The patient underwent the procedure successfully with reduction in vasopressors and thrombus burden and recovery of right ventricular function.

TCT-828 Very Late Vasomotor Responses and Gene Expression Profiles of Porcine Coronary Arteries at 4 Years after Deployment of the Everolimus-eluting Bioresorbable Vascular Scaffold and the Everolimus-eluting Metallic Xience V stent

nos: 825 844 TCT-825 Simplicity Denervation System for Pulmonary Artery Denervation in Patients with Chronic Thrombembolic Pulmonary Hypertension (first-in-man study) Boris Rudenko, Artem Shanoian, Sergey Boytsov, Oksana Drapkina, Svetlana Beregovskaya, Anna Akhadova, Daria Feshchenko, Vsevolod Vlasov, Firdavs Shukurov, Alexandr Koltunov, Sergey Dzemeshkevich, Yulia Frolova Moscow, Russian Federation; Nat. Rsrch Ctr for Preventive Med., Moscow, Russian Federation; National Center for Preventive Medicine; National Center for Preventive Medicine; National Center for Preventive Medicine; National Center for Preventive Medicine; National Center for Preventive Medicine; National Center for Preventive Medicine; National Center for Preventive Medicine; Central Military Hospital; National Center for Surgery; National Center for Surgery BACKGROUND The goal of our study was to evaluate the safety and effectivenessofSimplicitydenervationsystemin loweringpulmonaryartery pressure inpatientswith chronic thromboembolicpulmonaryhypertension. METHODS Patients with the chronic thromboembolic pulmonary hypertension (defined as mean pulmonary artery pressure > 25) were eligible for the study. A total of 12 patients were included. All patients were on the multidrug theraphy, including sildenafil. Functional capacity was determined by the 6MWT performed 1 week prior and 3 months following the PADN procedure. The right heart catheterization, hemodynamic measurements and blood oxygen saturation data from the RA, RV, and PA were done before the PADN procedure. The PVR [PVR 1⁄4 (mean PAP d PAOP)/CO] was calculated. The PADN procedure was made by Simplicity 6 Fr-compatible radiofrequency ablation catheter inserted through the coronary guiding catheter. Ablation was perfored at the bifurcation level of the main PA and at the ostium of the left and right PA. Procedural success was defined as a reduction in the mean PAP >10 mm Hg (as measured by guiding catheter at the end of ablation), and there were no complications. The primary endpoints were improvement of functional capacity by the 6MWT and mean PAP at 3 months. RESULTS During and immediately following the PADN procedure, no complications (death, arrhythmias, PA perforation, acute thrombus formation in the PA or in the femoral vein, bleeding) were recorded. During 3-months of follow-up no rehospitalization was required. All patients reported no deterioration of the symptoms and no complications were registered. 9 patients noticed significant improvements in dyspnea and fatigue, in all patients sildenafil was discontinued. After 3 months all patients underwent right heart catheterization and functional capacity measurements. At 3 months follow-up the reduction of mean pulmonary artery pressure was 25 mm Hg (from 58 6 to 33 4 mm Hg) (p < 0.01) and improvement of the 6 minutes walking test from 321 19 m to 487 29 m (p < 0.01) was observed. CONCLUSION The Simplicity denervation system is proven to be safe and effective for pulmonary artery denervation. Further randomized study is needed to confirm the clinical benefit of this procedures in patients with pulmonary hypertension. CATEGORIES OTHER: Pre-Clinical/First In-Human Studies TCT-826 Prospective single center First In Human (FIH) clinical trial to evaluate the safety and effectiveness of a septal occluder with bioresorbable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) Björn Söderberg, Laura Vaskelyte, Sameer Gafoor, Ilona Hofmann, Andreas Mellmann, Jerome Bernhard, Horst Sievert Atlanticare Medical Center; University of Missouri-Columbia, Frankfurt am Main, Germany; CardioVascular Center Frankfurt, Frankfurt, Germany; CVC, Frankfurt/Main, Germany; Carag, Baar, Switzerland; Unknown, Zurich, Switzerland; CardioVascular Center Frankfurt CVC, Sankt Katharinen, Frankfurt, Germany BACKGROUND The objective of this trial is to investigate the effectiveness and safety of a new septal occluder with bioresorbable framework (Carag Bioresorbable Septal Occluder CBSO, CARAG AG, Switzerland) in the treatment of secundum ASD or PFO. Device closure of ASD/PFO is standard of care in most countries. Current devices use a metal framework and occlusive patch material. Metal frameworks are reported to cause serious complications (eg erosion, perforation, arrhythmia) as late as 10 years following implantation. A septal occluder with bioresorbable framework has long been desired. Until now, development of a clinically effective bioresorbable framework has been elusive. We report on the initial 14 subjects implanted at the CardiovascularCenter, Frankfurt. METHODS The CBSO employs a poly lactic-co-glycolic acid (PLGA) framework with polyester patches. Available in 3 sizes, it treats defects 25mm balloon diameter. It is delivered over a guidewire via a 12F transseptal sheath under fluoro/TEE guidance. Follow-up is at 1, 6, 12 and 24 months & includes clinical examination echo, ECG & blood panel. Closure effectiveness is determined by TEE at 6 months. In this FIH trial, only ASD with atrial rims 5mm or PFO tunnels 4mm are treated. RESULTS 14 patients (age 50.5 11.4 years) have been treated: ASD (n1⁄48) ranged from 12.9-21mm in diameter, PFO (n1⁄46) ranged from 5.4-10.8mm in diameter. All devices were successfully implanted without complication. Mean time for loading and placement was 30 25.0 minutes. At 6 months, echo exam showed complete closure in 4/6 PFO patients and complete closure in 6/7 ASD and one small residual shunt (2mm). TTE at long term follow-up (2 at 24 months; 8 at 12 months) confirmed flat septum and showed no re-canalization. There have been no procedure or device related serious adverse events, no thrombus formation and no new occurring arrhythmias during follow-up. CONCLUSION CBSO is the first clinically effective septal occluder with a bioresorbable framework. It can be easily and safely implanted in humans with excellent closure results at procedure and long term. A learning curve may be required. Additional patients and longer follow-up is needed to further assess outcome. CATEGORIES OTHER: Pre-Clinical/First In-Human Studies TCT-827 Abstract Withdrawn TCT-828 Very Late Vasomotor Responses and Gene Expression Profiles of Porcine Coronary Arteries at 4 Years after Deployment of the Everolimus-eluting Bioresorbable Vascular Scaffold and the Everolimus-eluting Metallic Xience V stent Bill D. Gogas, sandeep kumar, James Benham, Deepal Panchal, Yasir Bouchi, Olivia Hung, Rounak Gandhi, Nikolaos Spilias, J O U R N A L O F T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y , V O L . 6 8 , N O . 1 8 , S U P P L B , 2 0 1 6 B335 Esha Singhal, Don P. Giddens, Alessandro Veneziani, Richard Rapoza, Spencer King III, Hanjoong Jo, Habib Samady Emory University School of Medicine, Atlanta, Georgia, United States; igic, patna, Bihar, India; Abbott Vascular, Santa Clara, California, United States; Emory Healthcare, Atlanta, Georgia, United States; Emory University Hospital, Lawrenceville, Georgia, United States; Decatur, Georgia, United States; Emory University School of Medicine; Emory University School of Medicine; Emory University; Emory University Department of Biomedical Engineering, Atlanta, Georgia, United States; Emory University, Atlanta, Georgia, United States; Abbott Vascular, Santa Clara, California, United States; Emory University, Atlanta, Georgia, United States; Emory University Department of Biomedical Engineering; Emory University Hospital, Atlanta, Georgia, United States BACKGROUND Coronary arteries demonstrate dysfunctional vasoreactivity after drug-eluting stent (DES) deployment, while bioresorbable vascular scaffolds (BVS) enable early functional restoration by 1 year (y). Very late (>2y) vasoactive responses and gene expression profiles of DES vs. BVS treated arteries have not been investigated. METHODS Ten Absorb BVS and 6 Xience V (XV) DES (AV, SC, Calif.) were randomly implanted in the coronaries of 6 non-atherosclerotic Yucatan mini swine, followed-up at 4y. In-segment % mean lumen diameter changes, following infusion of endothelial dependent and non-endothelial dependent vasoactive agents were estimated. Isolated coronary rings were placed in a tension apparatus and tension was measured using a force transducer to assess contractile performance after PGF2a administration. Gene analysis was performed in explanted coronary arterial segments using the MetaCoreTM Key Pathway Advisor. RESULTS In vivo: BVS segments showed significantly different % inscaffold vasoconstriction after acetylcholine compared to in-stent XV arterial segments at 4y:-35 25% vs -5 17%, (p1⁄40.035). BVS arteries demonstrated similar constrictive responses to control: -35 25% vs -54%, (p1⁄40.496) as well as expansive responses: 78 67% vs 125%, (p1⁄40.594). Edge responses were not significantly different. Ex vivo: Endothelial-dependent % relaxation induced by substance P, of BVS vs XV arteries within the stented segments was significantly different at 4y: 59 29% vs. 12 25%, (p1⁄40.007). Proximal and distal edges of both platforms showed similar endothelial-dependent % relaxation. Contractile performance of BVS vs XV segments was 2.99 1.97g vs 0.54 1.21g, (p1⁄40.003). Gene Analysis: Out of 12,000 genes, 499 showed differential expression (>1.5 fold change). The lymphotoxinbeta receptor (LTBR) pathway was shown to be significantly upregulated in the XV stented arteries. LTBR signaling pathway regulates transcription of genes that encode vascular cell adhesion molecules and interleukins. CONCLUSION Very late (4y) functional responses of BVS arteries are fully restored. Genetic analysis suggests sustained inflammatory expression even 4y after XV metallic stents are deployed in coronary arteries. CATEGORIES CORONARY: Stents: Bioresorbable Vascular Scaffolds TCT-829 Biomechanical Behavior and Healing Response of a Novel Thin Strut Sirolimus Eluting Bioresorbable Scaffold Overexpanded up to 0.75 mm B

In-hospital Outcomes of Attempting More Than One Chronic Total Coronary Occlusion Through Percutaneous Intervention During the Same Procedure

The frequency and outcomes of patients who underwent chronic total occlusion (CTO) percutaneous coronary intervention (PCI) of more than one CTO during the same procedure have received limited study. We compared the clinical and angiographic characteristics and procedural outcomes of patients who underwent treatment of single versus >1 CTOs during the same procedure in 20 centers from the United States, Europe, and Russia. A total of 2,955 patients were included: mean age was 65 ± 10xa0years and 85% were men with high prevalence of previous myocardial infarction (46%), and previous coronary artery bypass graft surgery (33%). More than one CTO lesions were attempted during the same procedure in 58 patients (2.0%) and 70% of them were located in different major epicardial arteries. Compared with patients who underwent PCI of a single CTO, those who underwent PCI of >1 CTOs during the same procedure had similar J-CTO (2.4 ± 1.3 vs 2.5 ± 1.3, pu202f=u202f0.579) and Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (1.5 ± 1.2 vs 1.3 ± 1.0 pu202f=u202f0.147) scores. The multi-CTO PCI group had similar technical success (86% vs 87%, pu202f=u202f0.633), but higher risk of in-hospital major complications (10.3% vs 2.7%, pu202f=u202f0.005), and consequently numerically lower procedural success (79% vs 85%, pu202f=u202f0.197). The multi-CTO PCI group had higher in-hospital mortality (5.2% vs 0.5%, pu202f=u202f0.005) and stroke (5.2%vs 0.2%, p <0.001), longer procedure duration (162 [117 to 242] vs 122 [80 to 186] minutes, p <0.001) and higher radiation dose (3.6 [2.1 to 6.4] vs 2.9 [1.7 to 4.7] Gray, pu202f=u202f0.033). In conclusion, staged revascularization may be the preferred approach in patients with >1 CTO lesions requiring revascularization, as treatment during a single procedure was associated with higher risk for periprocedural complications.

Myocardial perfusion imaging to guide percutaneous revascularization of chronic total occlusions: A gate keeper to the final frontier in PCI

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) is experiencing a renaissance due to novel equipment and techniques resulting in enhanced safety and rising success rates from 50% to the range of 80%-95%. This progress has challenged the prevailing therapeutic dogma of treating CTOs predominantly with either stand alone medical therapy or coronary bypass surgery (CABG) when there is sufficient global disease burden. In fact, in an era of appropriate use criteria the presence of a CTO can be significant determinant for referral for CABG. However, with lesion-specific physiologic assessment, a significant portion of non-CTO lesions in multi-vessel disease patients with CTOs are found to be non-hemodynamically significant, reducing the territories requiring revascularization and thus expanding percutaneous therapeutic options. Recent studies have documented benefits specific to successful CTO PCI with respect to improvement in symptoms, reduction in ischemia, and even a suggestion of better outcomes. However, in comparison with non-CTO PCIs, CTO PCI comes with a slightly higher risk of complications including coronary perforation, dissection, radiation-induced tissue damage, and contrast-induced nephropathy which can be mitigated by operator experience and careful patient selection. Angiographic features such as large amount of myocardium subtended by the CTO or the presence of brisk collateral blood vessels may suggest potential benefit of revascularization in a vessel with sufficient blood flow to permit normal resting contractile function but inadequate to prevent exercise-induced ischemia. Other angiographic features such as the length of the occlusion, the presence of an antegrade beak or funneled cap, occlusion length, degree of tortuosity, calcification, or connecting septal channels can be critical in determining the likelihood of successful PCI and ultimately assessing the risk/benefit ratio the procedure. However, the goals of CTO revascularization, and indeed any revascularization for chronic angina syndromes, are predominantly to treat symptoms refractory to medical therapy and reduce ischemia, with the hope of improving prognosis. Therefore, the upstream decision to consider CTO PCI has to be a clinical and scintigraphic one and therefore there is a pressing need for data relating non-invasive imaging features to CTO PCI outcomes. In this issue of the Journal, Wright et al retrospectively compare the association between ischemia on myocardial perfusion imaging (MPI) and the presence of collaterals on angiography with hard cardiac events (HCE) in 21 patients with CTOs treated medically over a mean follow up of 23 months (13-27 months range). The MPIs were retrospectively analyzed by a single observer and reported semi-quantitatively in a standard fashion with summed difference scores (SDS) of [1 defined as abnormal. Similarly, the angiograms were analyzed and the presence of collaterals was defined as Rentrop class [0. The authors found that 15 of 21 (71.4%) patients had ischemia on MPI and 8 of 21 (38.1%) patients had no collaterals. Furthermore, 9 of 15 (60.0%) patients with ischemia on MPI had HCE (P .01 compared to those without ischemia) and 5 of 8 (62.5%) patients without collaterals had HCE (P = .15 compared to those with collaterals). The authors concluded that MPI in patients with CTO accurately predicted HCE, with extremely high sensitivity and negative predictive value, allowing for accurate triage of patients by MPI for consideration of revascularization if technically feasible. From the Interventional Cardiology, Emory University Hospital, Atlanta, GA. Interventional Cardiology (111C/D), Atlanta VA Medical Center, Decatur, GA. Reprint requests: Habib Samady, MD, Interventional Cardiology, Emory University Hospital, 1364 Clifton Road, Suite F606, Atlanta, GA 30322; hsamady@emory.edu. J Nucl Cardiol 2013;20:504–5. 1071-3581/

Investigation of Wall Shear Stress Over an Early Atherosclerotic Plaque in the Left Coronary Artery of a Patient by Intravascular Ultrasound and Computational Fluid Dynamics

34.00 Copyright 2013 American Society of Nuclear Cardiology. doi:10.1007/s12350-013-9704-4

A Segmentation Method for Intracoronary Optical Coherence Tomography (OCT) Image Based on Least Squares Support Vector Machine: Vulnerable Coronary Plaque Cap Thickness Quantification

A small isolated region with mild atherosclerotic thickening in the left anterior descending (LAD) coronary artery was identified in a relatively young patient using invasive coronary angiography. The left main (LM) coronary artery and LAD were reconstructed based on biplanar angiography images and intravascular ultrasound (IVUS). The flow field in the lumen was simulated by computational fluid dynamics (CFD) with Doppler-measured flow boundary conditions. The results offer insight into the local flow environment in the neighborhood of an early atherosclerotic plaque in a specific human subject under in vivo conditions. The investigation is continuing with other patients who have mild plaques in the left coronary artery in an effort to elucidate in vivo atherogenesis.Copyright